A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants
| Autor: | Catherine Cohet, Brigitte Cheuvart, Leentje Moerman, Dan Bi, Adrian Caplanusi, Mallesh Kariyappa, Sanjay Lalwani, Monjori Mitra, Amita Sapru, Shruti Saha, P.V. Varughese, Rajeev Zachariah Kompithra, Sanjay Gandhi |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: | |
| Zdroj: | Human Vaccines & Immunotherapeutics, Vol 17, Iss 11, Pp 4646-4653 (2021) |
| Druh dokumentu: | article |
| ISSN: | 2164-5515 2164-554X 21645515 |
| DOI: | 10.1080/21645515.2021.1960136 |
| Popis: | The human rotavirus vaccine (HRV; Rotarix, GSK) is available as liquid (Liq) and lyophilized (Lyo) formulations, but only Lyo HRV is licensed in India. In this phase III, randomized, open-label trial (NCT02141204), healthy Indian infants aged 6–10 weeks received 2 doses (1 month apart) of either Liq HRV or Lyo HRV. Non-inferiority of Liq HRV compared to Lyo HRV was assessed in terms of geometric mean concentrations (GMCs) of anti-RV immunoglobulin A (IgA), 1-month post-second dose (primary objective). Reactogenicity/safety were also evaluated. Seroconversion was defined as anti-RV IgA antibody concentration ≥20 units [U]/mL in initially seronegative infants (anti-RV IgA antibody concentration |
| Databáze: | Directory of Open Access Journals |
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